Nasal gel dosed before cardiac surgery reduced S. aureus burden vs. placebo
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Key takeaways:
- Exeporfinium chloride nasal gel reduced S. aureus before and after cardiac surgery vs. placebo.
- The nasal gel is fast-acting with low risk for bacterial resistance.
- No adverse events were observed.
A bactericidal nasal gel administered during the 24 hours before cardiac surgery reduced the burden of Staphylococcus aureus carriage vs. placebo with no adverse events or surgical site infections, researchers reported.
The findings of this phase 2 trial were published in Infection Control & Hospital Epidemiology.
Image: Adobe Stock
“Methicillin-susceptible Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) are the most common causes of health care-associated infections in hospitals worldwide,” Julie E. Mangino, MD, professor emeritus in the division of infectious diseases at The Ohio State University, and colleagues wrote. “S. aureus carriers are at a higher risk of staphylococcal infections after surgery than noncarriers and are up to nine times more likely to develop surgical-site infections.”
Mangino and colleagues wrote that exeporfinium chloride (XF-73, Destiny Pharma) is a dicationic porphyrin derivative with rapid bactericidal properties and low risk for bacterial resistance developed as a nasal gel for the elimination of S. aureus and the prevention of postoperative surgical site infection.
The present multicenter, randomized, placebo-controlled, phase 2 study was designed to evaluate the effect of the nasal gel on nasal S. aureus burden compared with placebo in 83 adult patients undergoing cardiac surgery between Aug. 29, 2019, and March 29, 2021 (76% men; 3.6% in U.S.; 89.2% in Georgia; 7.2% in Serbia).
Participants received the nasal gel or a color-matched placebo in three doses in the 24 hours before surgery; a fourth dose immediately before cardiac surgery; and a fifth dose after surgery.
Nasal swab cultures were obtained before the next application of the nasal gel or placebo and converted to log10 colony-forming unit per milliliter (CFU/mL) to measure S. aureus burden at baseline and immediately before and after surgery.
Efficacy of the bactericidal nasal gel vs. placebo
The primary endpoint was change in S. aureus log10 CFU/mL from baseline to 1 hour before cardiac surgery.
The most common surgery was CABG (63.8%) followed by mitral valve replacement and/or repair (16.9%) and aortic valve replacement (16.9%).
The baseline nasal S. aureus log10 CFU/mL carriage was similar between the two groups.
After three doses of the nasal gel applied during the 24 hours before surgery, researchers observed a greater decrease in nasal S. aureus observed in the nasal gel group compared with placebo (2.842 vs. 0.469 log10 CFU/mL; mean difference between, 2.1 log10 CFU/mL; 95% CI, 2.7 to 1.5; P < .0001).
The decrease in S. aureus within 1 hour of closure was also greater in the nasal gel group compared with placebo (mean difference, 2.2 log10 CFU/mL; 95% CI, 2.7 to 1.6; P < .0001).
Overall, 83.7% of patients treated with the nasal gel had zero or at least a 2 log10 CFU/mL or more reduction in nasal S. aureus carriage within 1 hour before cardiac surgery, according to the study.
Nasal gel safety
In addition, Mangino and colleagues observed no surgical site infections among patients with a foreign implant during the study or follow-up periods of 1 month or 3 months; no treatment-emergent adverse events in either study group; no local reactions at the application site; and no significant changes to patient sense of smell during the study.
“Administration of XF-73 nasal gel < 24 hours prior to surgery rapidly and significantly reduced nasal S. aureus burden preoperatively,” the researchers wrote. “In this study, XF-73 nasal gel had a favorable safety profile in this patient population without any treatment-emergent adverse events related to the study drug nor placebo. No postoperative surgical site infections were observed in either study arm.”
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